BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESHEATH+

    MDR report key: 18274125 · Received December 6, 2023

    Report

    Report Number
    2015691-2023-18119
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 9, 2023
    Report Date
    March 14, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    UDI-DI
    00690103217360
    PMA / PMN Number
    K200258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO PRODUCT EVALUATION FINDINGS. SECTIONS B4, D9, G3, G6, H2, H3, H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, AND H10 HAS BEEN UPDATED. THE DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. THE RETURNED SHEATH WAS VISUALLY EVALUATED AND THE FOLLOWING WAS OBSERVED: LINER FULLY EXPANDED AS DESIGNED, DISTAL TIP TORN RADIALLY AND AXIALLY WITH A PIECE OF TIP MISSING AND NOT RETURNED, HDPE STRETCHING ALONG RADIAL AND AXIAL TEAR; SLANTED SCORE LINE PRESENT, AND SCRATCHES PRESENT ON SOFT TIP. DUE TO THE CONDITION OF THE RETURNED DEVICE (LINER FULLY EXPANDED AS DESIGNED, DISTAL TIP TORN), NO APPLICABLE FUNCTIONAL TESTING WAS ABLE TO BE PERFORMED. NO APPLICABLE DIMENSIONAL TESTING COULD BE PERFORMED, THE COMPLAINT WAS CONFIRMED THROUGH VISUAL EXAMINATION. IMAGING EVALUATION OF A 3MENSIO REVEALED THE FOLLOWING: PATIENT HAD TORTUOUS AND CALCIFIED ACCESS VESSEL INCLUDING NEAR BIFURCATION. THE COMPLAINTS FOR "SHEATH DISTAL TIP TORN" AND "SYSTEM COMPONENTS SEPARATE DURING USE" WERE CONFIRMED VIA RETURNED PRODUCT EVALUATION. HOWEVER, NO MANUFACTURING NON-CONFORMANCE WAS IDENTIFIED. REVIEW OF THE DHR AND LOT HISTORY DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINTS. A REVIEW OF MANUFACTURING MITIGATIONS SUPPORTS THAT THE SHEATH HAS PROPER INSPECTIONS IN PLACE TO DETECT ISSUES RELATED TO THE COMPLAINT EVENTS. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. FURTHERMORE, NO ABNORMALITIES WERE NOTED DURING DEVICE UNPACKING OR PREPARATION. PER THE COMPLAINT DESCRIPTION, "THE PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND RECEIVED A 26 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE. THERE WAS NO ABNORMALITY OBSERVED DURING INSERTION OF THE ESP OR A COMMANDER DELIVERY SYSTEM. AFTER WITHDRAWING THE ESP, IT WAS OBSERVED THAT THE TIP OF THE ESP WAS TORN AND MISSING." ADDITIONALLY, PER THE EVENT DESCRIPTION, "REGARDING THE ACCESS VESSEL, THE DEGREE OF CALCIFICATION WAS MODERATE, TORTUOSITY WAS MILD, AND THE MINIMUM LUMINAL DIAMETER (MLD) WAS 6.8 MM.". PER PRODUCT EVALUATION, THE SHEATH DISTAL TIP WAS TORN RADIALLY ALONG THE DISTAL EDGE OF THE LINER, AS WELL AS AXIALLY, WITH A PIECE OF THE TIP MISSING. THIS FAILURE MODE IS CHARACTERISTIC OF SHEATH TIP TEAR EVENTS AS DESCRIBED IN A PRODUCT RISK ASSESSMENT. WHILE A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED, PREVIOUS INVESTIGATION INDICATED THAT THE TEAR IS ATTRIBUTED TO IMPROPER TIP EXPANSION, WHICH CAN CREATE INTERFERENCE BETWEEN THE VALVE AND SHEATH TIP. WHILE NO ABNORMALITIES WERE NOTED DURING SHEATH/DS INSERTION AND ADVANCEMENT, PATIENT HAD TORTUOUS AND CALCIFIED ACCESS VASCULATURE, AS CONFIRMED VIA 3MENSIO. THE RETURNED DEVICES HAD PRESENCE OF SCRATCHES ON SOFT TIP, WHICH FURTHER INDICATES THAT THE DISTAL PORTION OF E-SHEATH WOULD HAVE BEEN INTERACTING WITH CALCIUM. CALCIFICATION CAN CREATE A CONSTRAINED EFFECT ON THE SHEATH LEADING TO SUB-OPTIMAL CONDITIONS FOR DISTAL TIP EXPANSION. CALCIFICATION AND TORTUOSITY CAN ALSO LEAD TO NON-COAXIAL ALIGNMENT BETWEEN THE DELIVERY SYSTEM AND THE SHEATH, WHICH MAY LEAD TO THE VALVE STRUTS TO CATCH ON TO THE SHEATH DISTAL TIP. IT IS ALSO POSSIBLE THAT THE TORN TIP SEPARATED DURING SHEATH REMOVAL BY POTENTIALLY CATCHING ONTO THE ACCESS SITE OR CALCIFICATION. AS SUCH, DISTAL TIP TEAR AND SEPARATION MAY BE RELATED TO IMPROPER EXPANSION OF THE SHEATH TIP DURING THV ADVANCEMENT AND/OR PATIENT FACTORS (TORTUOSITY, CALCIFICATION). HOWEVER, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 0

    PER REPORT RECEIVED FROM JAPAN, THE PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND RECEIVED A 26 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE. THE ESHEATH+ (ESP) WAS INSERTED FROM THE RIGHT FEMORAL ARTERY (RT-FA) VIA A PUNCTURE. DURING DEVICE PREPARATION, NO DAMAGE WAS OBSERVED ON THE ESP. THERE WAS NO ABNORMALITY OBSERVED DURING INSERTION OF THE ESP OR A COMMANDER DELIVERY SYSTEM. AFTER WITHDRAWING THE ESP, IT WAS OBSERVED THAT THE TIP OF THE ESP WAS TORN AND MISSING. ECHOCARDIOGRAPHY, ANGIOGRAPHY, COMPUTED TOMOGRAPHY (CT) AND CUTTING DOWN OF ACCESS SITE WERE PERFORMED TO CHECK IF THERE WAS MISSING TIP REMAINED IN THE PATIENT'S BODY, BUT MISSING TIP COULD NOT BE FOUND. SINCE NO PATIENT INJURY SUCH AS VASCULAR COMPLICATION OR DISTURBED CONSCIOUSNESS WAS OBSERVED, THE PATIENT RETURNED TO THE ICU AND WAS PUT UNDER OBSERVATION. PER PHYSICIAN OPINION, NO ABNORMALITY WAS OBSERVED DURING PROCEDURE. PER FOLLOW-UP INFORMATION, THE PATIENT RECOVERED WITHOUT PROBLEMS AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232316 ESHEATH+ INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 914ESPJ 65048456 00690103217360

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female